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Grit Biotechnology's GT201 TIL Therapy Receives FDA Clearance for Advanced Solid Tumor Trial

• Grit Biotechnology's GT201, a genetically engineered tumor-infiltrating lymphocyte (TIL) therapy, has been cleared by the FDA for clinical trials in advanced solid tumors. • GT201 leverages Grit's StemTexp platform and StaViral transduction system to enhance T-cell survival and function without heavy reliance on IL-2. • Early clinical data presented at ASGCT and ASCO demonstrated GT201's stable in-vivo expansion and preliminary efficacy with a good safety profile in advanced solid tumor patients. • Grit Biotechnology is also advancing GT101, a non-genetically engineered TIL product, with plans to submit a biologics license application in China in 2025.

Grit Biotechnology has announced that the FDA has cleared its investigational new drug (IND) application for GT201, a genetically engineered tumor-infiltrating lymphocyte (TIL) therapy, for a clinical trial in patients with advanced solid tumors. This decision marks a significant step forward in the development of novel cell therapies for challenging cancers.

GT201: Enhancing TIL Therapy

GT201 is based on Grit Biotechnology’s StemTexp proprietary stemness TIL expansion platform and StaViral stable virus transduction system. The therapy expresses a membrane-bound cytokine complex designed to enhance T-cell survival and function. According to Grit, GT201 differentiates itself from traditional TIL therapies by reducing its dependence on IL-2, potentially leading to improved proliferation, tumor-killing ability, and long-term survival. The therapy previously received IND clearance from China’s Center for Drug Evaluation in July 2023.

Early Clinical Data

Early clinical and preclinical data regarding GT201 were presented at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting and the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. These presentations highlighted findings from a first-in-human trial, where GT201 demonstrated stable in-vivo expansion and preliminary clinical efficacy in patients with advanced solid tumors. The safety profile observed in these patients was characterized as "good."

Grit's Broader Pipeline

In addition to GT201, Grit Biotechnology is developing GT101, a TIL product that is not genetically engineered. GT101 is currently in the pivotal stage of clinical development, with the company aiming to submit a biologics license application for GT101 in China in 2025.
Yarong Liu, PhD, the founder and chief executive officer of Grit Bio, stated, "The clinical exploration of next-generation TIL products is still in its early stages globally, and the rapid advancement of the GT201 pipeline reflects our innovation and product development strength on a global scale. Moving forward, we will accelerate global clinical development to provide more treatment options for patients with advanced solid tumors."
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Reference News

[1]
Grit Biotechnology's TIL Therapy GT201 Cleared for US Trial in Advanced Solid Tumors
cgtlive.com · Sep 3, 2024

Grit Biotechnology received FDA clearance for GT201, a genetically-engineered TIL therapy for advanced solid tumors, bas...

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